Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06096207
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-09-18
Brief Title:
DBS for Depression
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Deep Brain Stimulation DBS Therapy for Treatment Resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unanticipated problem observed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression The main questions it aims to answer are
Is deep brain stimulation effective in treating treatment resistant depression
Does deep brain stimulation improve overall clinical well-being and functioning
Participants will be implanted with a deep brain stimulation device They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms The device will be turned off at certain time points unbeknown to the participant to show the efficacy of the device when it is turned on The device will be ON for 85 months and OFF for 35 months during the first year
Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression
Is deep brain stimulation effective in treating treatment resistant depression
Does deep brain stimulation improve overall clinical well-being and functioning
Participants will be implanted with a deep brain stimulation device They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms The device will be turned off at certain time points unbeknown to the participant to show the efficacy of the device when it is turned on The device will be ON for 85 months and OFF for 35 months during the first year
Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression
Detailed Description:
This initial study at Northwell Health has the purpose to demonstrate the feasibility and safety of performing slMFB DBS as a treatment for TRD at Northwell Health as well as more clearly establish efficacy The investigators hypothesize that DBS targeting can be consistently placed in the supero-lateral branch of the medial forebrain bundle slMFB after identification using diffusion tensor imaging and fiber tract analysis as performed in DBS at UTHealth The investigators will implant the Medtronic SenSight Directional DBS lead at this target location
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None